510(k) K971853 ยท HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
ENDOVIEW SPPHIRE LENS SET
| Applicant | American Medical Devices, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Aug 6, 1997 |
| Received | May 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971853
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.